Clinical Trials
Immunotherapy Clinical Trials at UNC Lineberger
UNC Lineberger’s Clinical Immunotherapy Program is conducting chimeric antigen receptor T-cell (CAR-T) clinical trials and other cellular immunotherapy clinical trials that are currently open for patient accrual. These experimental treatments involve re-engineering cells from the patient’s immune system to recognize and direct the attack against the patient’s cancer. We offer both pediatric and adult immunotherapy clinical trials.
Pediatric Immunotherapy Clinical Trials
Relapsed/Refractory Acute Lymphoblastic Leukemia
LCCC1541-ATL (NCT03016377): Phase I Study of the Administration of Autologous CAR-T Cells Targeting the CD19 Antigen and Containing the Inducible Caspase9 Safety Switch in Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia
The primary purpose of this study is to determine whether receiving iC9-CAR19 cells is safe and tolerable and later to determine an optimal dose of AP1903 to be given to subjects to alleviate severe cytokine release syndrome or neurological complications from CAR T cell therapy.
Principal Investigator: Natalie Grover, MD
Relapsed/Refractory CD30+ Hodgkin’s Lymphoma and CD30+ Non-Hodgkin’s Lymphoma
LCCC1532-ATL (NCT02690545): Phase Ib/II Study of the Administration of T lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Relapsed/Refractory CD30+ Hodgkin’s Lymphoma and CD30+ Non-Hodgkin’s Lymphoma
This trial studies the efficacy of CAR T cells targeting CD30 in treating patients with relapsed/refractory CD30+ Hodgkin lymphoma or non-Hodgkin lymphoma that expresses CD30. Patients who have failed treatment with autologous or allogeneic stem cell transplantation are eligible for this therapy.
Principal Investigator: Anne Beaven, MD
Relapsed/Refractory Neuroblastoma/Relapsed/Refractory Osteosarcoma
LCCC1743-ATL (NCT03721068): A Phase I Study of Autologous Activated T-Cells Expressing a 2nd Generation GD2 Chimeric Antigen Receptor, IL-15, and iCaspase9 Safety Switch Administered To Patients with Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma
This trial combines two different ways of fighting disease: antibodies and T cells. Both antibodies and T cells have been used to treat patients with cancers, and both have shown promise, but neither alone has been sufficient to cure most patients. The primary purpose of this study is to determine whether receiving iC9.GD2.IL-15 T cells is safe and tolerable in patients with relapsed/refractory neuroblastoma or relapsed/refractory osteosarcoma.
Principal Investigator: George Hucks, MD
Adult Immunotherapy Clinical Trials
Relapsed/Refractory Acute Lymphoblastic Leukemia
LCCC1541-ATL (NCT03016377): Phase I Study of the Administration of Autologous CAR-T Cells Targeting the CD19 Antigen and Containing the Inducible Caspase9 Safety Switch in Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia
The primary purpose of this study is to determine whether receiving iC9-CAR19 cells is safe and tolerable and later to determine an optimal dose of AP1903 to be given to subjects to alleviate severe cytokine release syndrome or neurological complications from CAR-T cell therapy.
Principal Investigator: Natalie Grover, MD
Relapsed/Refractory Triple Negative Breast Cancer
LCCC2128-ATL (NCT06347068): Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells
The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9-CAR.B7-H3 T cells) in patients with relapsed/refractory triple-negative breast cancer (TNBC). The iC9.CAR.B7-H3 treatment is experimental and has not been approved by the Food and Drug Administration. The study team wants to know how much (dose) of the iC9-CAR.B7-H3 T cells are safe to use in patients without causing too many side effects and what is the maximum dose that can be tolerated.
Principal Investigators: Claire Dees, MD, ScM, and Yara Abdou, MD
Nonseminomatous Germ Cell Tumors
LCCC2048-ATL (NCT05634785): Phase 2 Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Patients With CD30+ Nonseminomatous Germ Cell Tumors (NSGCT)
The purpose of this study is to create a repository and explore the presence of modified T cells in the subject’s plasma or tumors. This research study combines two different ways of fighting disease: antibodies and T cells. They both have shown promise, but neither alone has been sufficient to cure most patients. This study is designed to combine both T cells and antibodies to create a more effective treatment called autologous T lymphocyte chimeric antigen receptor cells targeted against the CD30 antigen (ATLCAR.CD30) administration.
Principal Investigator: Matthew Milowsky, MD, FASCO
Relapsed/Refractory Glioblastoma
LCCC2059-ATL (NCT05366179): Phase 1 Study of Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc
This is a single center, open-label study aims to determine the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells targeting the B7-H3 antigen administered via intraventricular infusion to adult subjects with relapsed or refractory glioblastoma.
Principal Investigator: Yasmeen Rauf, MD
Relapsed/Refractory Head and Neck Squamous Cell Carcinoma
LCCC2060-ATL (NCT06096038): Autologous CAR-T Cells Targeting CSPG4 in Relapsed/Refractory HNSCC
The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the CSPG4 antigen (iC9.CAR-CSPG4 T cells) in patients with head and neck cancer that came back after receiving standard therapy for this cancer. The iC9.CAR-CSPG4 treatment is experimental and has not been approved by the Food and Drug Administration.
Principal Investigator: Jared Weiss, MD
Relapsed/Refractory Kappa+ Mantle Cell and Indolent Non-Hodgkin Lymphoma
LCCC1811-ATL (NCT04223765): Phase 1 Study of the Administration of T lymphocytes Expressing the Kappa Chimeric Antigen Receptor (CAR) and CD28 Endodomain for Relapsed/Refractory Kappa+ Mantle Cell and Indolent Non-Hodgkin Lymphoma
This Phase 1 study will combine both T cells and antibodies in order to create a more effective treatment. The treatment tested in this study uses modified T-cells called Autologous T Lymphocyte Chimeric Antigen Receptor (ATLCAR) cells targeted against the kappa light chain antibody on cancer cells. The purpose of this study is to determine whether receiving the ATLCAR.κ.28 cells is safe and tolerable and learn more about the side effects and how effective these cells are in fighting lymphoma.
Principal Investigator: Natalie Grover, MD
Relapsed/Refractory B cell Non-Hodgkin Lymphoma
LCCC1813-ATL (NCT03696784): Administration of Autologous CAR-T Cells Targeting the CD19 Antigen and Containing the Inducible Capsase 9 Safety Switch in Patients with Relapsed/refractory B-cell Non-Hodgkin Lymphoma
This Phase 1 study is the first step in determining whether giving iC9-CAR19 cells can be used to treat lymphoma and to determine if AP1903 can be used to successfully activate the safety switch in the iC9-CAR19 cells limiting the severity of cytokine release syndrome and/or neurotoxicity.
Principal Investigator: Natalie Grover, MD
Relapsed/Refractory CD30+ Peripheral T Cell Lymphoma
LCCC1904-ATL (NCT04083495): Phase II Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Relapsed/Refractory CD30+ peripheral T Cell Lymphoma
This is a research study to determine the safety and tolerability of ATLCAR.CD30 for treating relapsed/refractory peripheral T cell lymphoma. To prepare the body for the ATLCAR.CD30 cells, participants will complete lymphodepletion with two chemotherapy agents.
Principal Investigator: Anne Beaven, MD
CD30+ Relapsed/Refractory Hodgkin Lymphoma and CD30-expressing T cell lymphoma
LCCC1606-ATL (NCT03602157): Phase I Study of the Administration of Autologous CAR-T cells Targeting the CD30 Antigen and Expressing CCR4 in Patients with CD30+ Relapsed/Refractory Hodgkin Lymphoma and CD30-expressing T cell lymphoma
The trial evaluates the safety and tolerability of CAR T cells targeting CD30 in patients with CD30-expressing Hodgkin or T cell lymphomas, including cutaneous T cell lymphomas. The trial also evaluates whether the inclusion of CCR4 into the CAR treatment will enhance the presence of CAR-T cells at tumor sites.
Principal Investigator: Natalie Grover, MD
Hodgkin’s lymphoma
LCCC2222-ATL (NCT06090864): ATLCAR.CD30.CCR4 for CD30+ HL ATLCAR.CD30.CCR4 Cells
The purpose of this study is to determine the tolerability of ATLCAR.CD30.CCR4 cells in subjects with Hodgkin’s Lymphoma and identify a recommended dose for further.
This is a single-center, open-label phase Ib/II trial that uses a 3+3 design to identify a recommended phase 2 dose (RP2D) of ATLCAR.CD30.CCR4 cells in Hodgkin’s Lymphoma. The phase II portion is designed to determine the PFS of ATLCAR.CD30.CCR4 in Hodgkin’s lymphoma.
Principal Investigator: Natalie Grover, MD
Autologous CAR T-Cells Targeting the GD2 Antigen for Lung Cancer
LCCC2115-ATL (NCT05620342): Administration of T Cells Expressing a 2nd Generation GD2 Chimeric Antigen Receptor, IL-15, and iCaspase9 Safety Switch in Subjects With Lung Cancer
This is a phase 1, single-center, open-label study that enrolls adult subjects with extensive stage lung cancer or stage IV non-small cell lung cancer that is platinum-refractory and received PD-1 and/or PD-L1 therapy. The purpose of this study is to test the safety of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the GD2 antigen (iC9-GD2.CAR.IL-15 T cells) in subjects with lung cancer. How much (dose) of the iC9-GD2.CAR.IL-15 T cells are safe to use without causing too many side effects and what is the maximum dose that could be tolerated will be studied.
Principal Investigator: Jared Weiss, MD
Metastatic Non-Small-Cell Lung Cancer
IOV-LUN-202 (NCT04614103): Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients With Metastatic Non-Small-Cell Lung Cancer
LN-145 is a ready-to-infuse, autologous TIL therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI and further optimized by Iovance for the treatment of patients with metastatic non-small-cell lung cancer. The cell transfer therapy used in this study involves patients receiving an NMA lymphocyte depleting preparative regimen, followed by infusion of autologous TIL, then finally followed by the administration of IL-2.
Principal Investigator: Jared Weiss, MD
Relapsed/Refractory Multiple Myeloma
LCCC1603-ATL (NCT03672318): Phase I Study of the Administration of Autologous CAR-T cells Targeting the CD138 Antigen in Patients with Relapsed/Refractory Multiple Myeloma
The primary purpose of this study is to determine whether the administration of CAR-T cells targeting CD138 is safe and tolerable and to evaluate an optimal dose of cells to give as treatment.
Principal Investigator: Sascha Tuchman, MD
Relapsed/Refractory Neuroblastoma/Relapsed/Refractory Osteosarcoma
LCCC1743-ATL (NCT03721068): A Phase I Study of Autologous Activated T-Cells Expressing a 2nd Generation GD2 Chimeric Antigen Receptor, IL-15, and iCaspase9 Safety Switch Administered To Patients with Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma
This trial combines two different ways of fighting disease: antibodies and T-cells. Both antibodies and T-cells have been used to treat patients with cancers, and both have shown promise, but neither alone has been sufficient to cure most patients. The primary purpose of this study is to determine whether receiving iC9.GD2.IL-15 T cells is safe and tolerable in patients with relapsed/refractory neuroblastoma or relapsed/refractory osteosarcoma.
Principal Investigator: George Hucks, MD
Relapsed/Refractory Platinum-resistant Epithelial Ovarian Cancer
LCCC2152-ATL (NCT06305299): Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells
The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9-CAR.B7-H3 T cells) in patients with ovarian cancer that came back after receiving standard therapy for this cancer. The iC9.CAR.B7-H3 treatment is experimental and has not been approved by the Food and Drug Administration. The study wants to know how much (dose) of the iC9-CAR.B7-H3 T cells are safe to use in patients without causing too many side effects and what is the maximum dose that can be tolerated.
Principal Investigator: Linda Van Le, MD
Refractory Pancreatic Ductal Adenocarcinoma
LCCC2223-ATL (NCT06158139): Autologous CAR-T Cells Targeting B7-H3 in PDAC
The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9.CAR.B7-H3 T cells) in patients with pancreatic ductal adenocarcinoma that came back after receiving standard therapy for this cancer. The iC9.CAR.B7-H3 treatment is experimental and has not been approved by the Food and Drug Administration. The study team wants to know how much (dose) of the iC9-CAR.B7-H3 T cells are safe to use in patients without causing too many side effects and what is the maximum dose that can be tolerated.
Principal Investigator: Ashwin Somasundaram, MD
Sponsored Clinical Trials
Relapsed/Refractory B cell Malignancies
P-CD19CD20-ALLO1-001 (NCT06014762): Allogeneic CAR-T Cells in the Treatment of Subjects With B Cell Malignancies
The purpose of this phase 1, open-label, dose escalation and expansion cohort study is to evaluate the safety, tolerability and response of P-CD19CD20-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed/refractory B cell malignancies.
Sponsor: Poseida Therapeutics
HER2+ Solid Tumor Malignancies
CT-0525-102 (NCT06254807): CAR-monocytes for the Treatment of HER2 Overexpressing Solid Tumors
This is a first-in-human open-label study to evaluate the safety and tolerability, and manufacturing feasibility of anti-HER2 CAR-monocytes (CT-0525) in participants with locally advanced (unresectable) or metastatic solid tumors overexpressing HER2 whose disease has progressed on standard approved therapies.
Sponsor: Carisma Therapeutics, Inc.
Severe, Refractory Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy or Systemic Sclerosis
CA061-1001 (NCT05869955): A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Disease
The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 (a CD19-targeted Nex-T CAR-T cell) in participants with severe, refractory autoimmune diseases.
Sponsor: Juno Therapeutics, Inc.
Active Systemic Lupus Erythematosus
CAB-201 (NCT06121297): RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a chronic autoimmune disorder characterized by autoantibody production and abnormal B cell function. SLE presents with fluctuating severity and may cause tissue damage in a variety of organs over time. Lupus nephritis (LN) (renal involvement) is a common severe manifestation of SLE, which can lead to significant morbidity and mortality. This study is being conducted to evaluate the safety and efficacy of an investigational cell therapy, CABA-201, that can be given to patients with either LN or SLE without renal involvement, in two separate parallel cohorts, who have active disease. A single dose of CABA-201 in patients who are pretreated with a standard regimen including cyclophosphamide and fludarabine will be evaluated.
Sponsor: Cabaletta Bio
Antigen-positive Locally Advanced (Unresectable) or Metastatic Solid Tumors
TSCAN-002 (NCT05973487): A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors
TScan Therapeutics is developing cellular therapies across multiple solid tumors in which autologous participant-derived T cells are engineered to express a T cell receptor that recognizes cancer-associated antigens presented on specific Human Leukocyte Antigen (HLA) molecules.
This is a multi-center, non-randomized, multi-arm, open-label, basket study evaluating the safety and preliminary efficacy of single and repeat dose regimens of TCR’Ts as monotherapies and as T-Plex combinations after lymphodepleting chemotherapy in participants with locally advanced, metastatic solid tumors disease.
Sponsor: TScan Therapeutics, Inc.
Relapsed/Refractory Multiple Myeloma
CA088-1000 (NCT06297226): Study of BMS-986393 a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma (QUINTESSENTIAL)
The purpose of this study is to evaluate the effectiveness and safety of BMS-986393, a GPRC5D-directed CAR T Cell Therapy, in participants with relapsed or refractory multiple myeloma.
Sponsor: Bristol Myers Squibb
Severe Sickle Cell Disease
EM-SCD-301-001 (NCT04853576): A Study Evaluating the Safety and Efficacy of EDIT-301 in Participants With Severe Sickle Cell Disease (RUBY)
This is a Phase 1/2 single-arm, open-label, multicenter study evaluating the safety and efficacy of a single unit dose of EDIT-301 for autologous hematopoietic stem cell transplant (HSCT) in subjects with severe SCD. Planned study subjects will be comprised of male and female adult and adolescent subjects with severe SCD, from 12 to 50 years of age, inclusive.
Sponsor: Edita Medicine, Inc.